Regulatory Affairs – Biologics

• Preparation and submission of dossiers for EMB, country-specific dossiers, CTD, ACTDand eCTD.

• Responsible for assigned products - Master dossier upgradation.

• Query response preparation and submission in emerging market

• Co-ordination with BD team, country manager and international regulatory agencies forregistration of products for emerging market

• Post-approval change application for the approved products in emerging market forcommercial support

• Supporting global filing, and preparation of briefing packages.

• Supporting in routine activities like artwork management, incoming document review, Gapanalysis. Business development support etc.

• Supporting Domestic activities like preparation, review and submission to CDSCO/ FDCA

• Post-approval change application for the approved products

• Regulatory knowledge sharing: Read and share new regulatory guidelines, trends, expectations and compliance documents. Do impact analysis with internal product development strategies. Acquire knowledge of the activities in new territories and keep upto date with current requirements.

• Interact, develop and maintain relationships with regulatory / drug control authorities /government agencies and other external regulatory experts.

• Coordination with Mfg. sites for documents arrangements, samples arrangement for EMB submissions.

Key competencies expected:

• Good understanding of Biotech process and Analytical

• Supported Regulatory Affairs for dossier preparation, review and query response

• Overall understanding of product development